U.S. FDA advisory meetings through Feb 27
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EST/GMT.
PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE
DATE: Jan. 7-8, 0800/1300
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: Diem-Kieu Ngo, 301-827-7001
On Jan. 7, the committee will discuss a new drug application from Ovation Pharmaceuticals, Inc for vigabatrin for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults.
On Jan. 8, the committee will discuss a new drug application from Ovation Pharmaceuticals for vigabatrin for the proposed indication of treatment of infantile spasms.
BLOOD PRODUCTS ADVISORY COMMITTEE
DATE: Jan 9, 0800/1300
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: William Freas, 301-827-0314
In the morning, the committee will discuss CSL Behring's (CSL.AX) application for plasma-derived fibrinogen concentrate for treatment of bleeding in congenital fibrinogen deficiency. In the afternoon, the committee will hear an update on the "Food and Drug Administration Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs." Included in the update will be an overview of the Center of Veterinary Medicine's review of the new animal drug application pertaining to the genetically engineered animals producing milk that contains recombinant Antithrombin III and of the environmental assessment for that application.
Following this update, the committee will discuss GTC Biotherapeutics' (GTCB.O) application for recombinant Antithrombin III derived from genetically engineered goats for treatment of patients with hereditary Antithrombin III deficiency to prevent thrombosis during high risk situations like surgery and obstetrical procedures.
JOINT MEETING OF THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE: Jan 30, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Kalyani Bhatt, 301-827-7001
The committee will discuss the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid (HCL), napsylate salts and combination drugs) and whether any regulatory action is appropriate.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: Feb. 3, 0800/1300
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committee will discuss a new drug application for Eli Lilly (LLY.N) and Daiichi Sankyo's (4568.T) prasugrel hydrochloride film coated oral tablets, 5 milligrams and 10 milligrams, for the proposed indication for use in acute coronary syndrome.
MEETING OF THE RISK COMMUNICATION ADVISORY COMMITTEE
DATE: Feb 26-27, 0800/1300
LOCATION: National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594
CONTACT: Lee Zwanziger, 301-827-2895
On both days there will be a discussion of different types of prescription drug information currently available to patients in the form of Medicating Guides, Patient Package Inserts, and Consumer Medication Information. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)
